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Parallel Offset Curette Set
KOROS U.S.A., INC. · Model 7421-00 · UDI-DI 10840199543783
FZS
Prescription
10
510(k) clearances
71
Adverse events (1 deaths)
3
Recalls
219
Facilities
Description
Parallel Offset Curette Set Consists of the Following; 1 x 7421-01, 1 x 7421-02, 1 x 7421-03, 1 x 7421-04, 1 x 7421-05, 1 x 7421-06, 1 x 7421-07, 1 x 7421-08, 1 x 7421-09, 1 x 7421-10, 1 x 7421-11, 1 x 7421-12 & 1 x 7421-26
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-12-03 | Sklar Instruments | Reports of various packaging issues that may result in a breach of the sterile barrier. |
| 2013-11-05 | Zimmer, Inc. | Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged pr |
| 2011-07-15 | X Spine Systems Inc | The firm learned that the Torque Driver Handles were not actuating at a proper torque. It was determined that the handles were speed determinant and could output a higher torque i |
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